As more potent and effective therapies have become available for use, the task of managing their known, significant risks has become increasingly challenging. Yet we know little about the effects of new approaches to managing risk, including educational interventions and methods of restricting distribution of such products. To address gaps in our knowledge about the effectiveness and impact of these new approaches, the Centers for Education & Research on Therapeutics (CERTs) are planning a scientific workshop, Managing the Risks of Therapeutic Products, for January 12-14, 2003. This workshop has two aims: 1. To explore current and future methods of managing the risks of FDA-approved therapeutic products to ensure maximum benefit and safety for patients. 2. To develop a research agenda to monitor the effectiveness of these risk-management approaches and their aggregate effects on patients and the healthcare system. These aims support and facilitate objective #17 of Healthy People 2010, "To ensure the safe and effective use of medical products," particularly in monitoring drugs and adverse events and providing useful data about the safe use of drugs. We expect that participants will assess current and future methods of managing the risks of therapies against criteria that will extend to all populations: urban, rural, and low-income groups; racial and ethnic minorities; women; children; the elderly; and those with special health needs. Because extensive involvement of patients is critical to success in managing risks of therapeutics, patient groups will speak and participate in the meeting. This workshop will be one of five "think-tank" sessions about the risks associated with therapeutic products (the Risk Series). The Risk Series is being conducted under the aegis of the CERTs in collaboration with the Agency for Healthcare Research and Quality (AHRQ), the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA). The CERTs mission is to serve as a trusted national resource for people seeking to improve health through the best use of medical therapies. To achieve this mission, the CERTs conduct research and provide education about efforts to optimize the use of drugs, devices, and biological products.